Pivotal Trial Begins for Cardiac Dimensions' Carillon Mitral Contour System
September 19, 2018—Cardiac Dimensions, Inc. announced that the first patient has been randomized in the CARILLON pivotal trial, which is evaluating the company's Carillon mitral contour system for the treatment of functional mitral regurgitation (FMR) associated with heart failure (HF) as compared to a randomized control group treated with optimal medical management according to established HF guidelines.
The multicenter, double-blinded, randomized controlled trial is expected to randomize 450 patients at up to 75 centers in North America and Europe. The trial has 12-month primary safety and efficacy endpoints and will follow randomized patients out to 5 years to document long-term safety and clinical status. The CARILLON trial also includes a crossover feature that allows patients originally randomized to the control group to receive the Carillon system after their 1-year follow-up visit.
Samir Kapadia, MD, one of the principal investigators of the CARILLON trial, commented in the company's announcement, “Current treatments to improve the quality of life for patients with FMR fall short and many HF patients are too frail for open heart surgery. Transcatheter treatments have been shown to be safe and effective in the treatment of valve diseases, but there is no minimally invasive intervention yet approved in the United States for these patients. Today, most FMR patients are treated with medical therapy only for decreasing symptoms, but this does not address the underlying anatomic problem leading to MR. The CARILLON trial should provide us a better understanding of the benefits of the Carillon system as an option for HF patients with FMR.” Dr. Kapadia is an interventional cardiologist and Catheterization Lab Director at the Heart & Vascular Institute at the Cleveland Clinic in Cleveland, Ohio.
The first patient in the CARILLON trial was randomized by Professor Tomasz Siminiak, MD, Professor of Cardiology at Poznan University of Medical Sciences in Poznań, Poland. Prof. Siminiak stated, “We are very excited to participate in this landmark trial to study the Carillon system for patients with FMR. These patients need access to less invasive treatment options and to be able to contribute to advancements that have the potential to slow the progression of this chronic disease is very important to us.”
The company will announce the results of its landmark REDUCE FMR trial—the first randomized, blinded evaluation of a therapy for FMR—at TCT 2018, the Transcatheter Cardiovascular Therapeutics conference being held September 21–25 in San Diego, California. Additionally, the CARILLON trial, continues to enroll patients.